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NCT Number: NCT02779218

Combination of Motor Imagery Exercises and Brain Stimulation TMS Type PAS in Patients After Hemiplegic Stroke

Strokes represent, in industrialized countries the leading cause of acquired motor disability in adults older than 40. Stroke is responsible for France from 150 000 to 200 000 new cases of hemiplegia each year. These patients will see their deficit to improve during the first 6 months after stroke. This recovery is largely based on brain plasticity mechanisms and the rehabilitation has as main objective to optimize these mechanisms. However, only 20% of patients hospitalized in a rehabilitation sector recover a functional upper limb. This lack of functionality is not only due to overall strength gap but also to the predominance of this gap on the extension movements of the wrist and fingers.

Meanwhile, work on brain plasticity helped develop new techniques of non-invasive brain stimulation (Non-invasive Brain Stimulation, NIBS) as the model of coupled stimulations (Paired Associative Stimulation, PAS) for modulating way over effective brain plasticity. In previous studies, the investigators have shown over a 30 minutes session lasting facilitation (60mn) and specific motor evoked potential (MEP) of the Extensor Carpi Radialis (ECR). Several studies showed an adjuvant effect when GSIN were associated with learning of a motor task. For PAS, some studies have shown a greater facilitation when the latter is associated with muscle contraction.

The motor imagery (MI) is imagining a movement without realizing it, it is based on mechanisms similar to those of the real movement. This technique also showed its effects as an adjuvant therapy in hemiplegic patients, however, they remain lower than those obtained after a motor drive. Its use in patients with no motor makes its uniqueness and strength.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Rangueil

Toulouse, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-85 years
  • Patients who have experienced a Stroke of more than one month
  • Deficit out of the upper limb (Fugl Meyer member sup <50/66)
  • Presence of ECR muscle MEP
  • Able to carry the motor imagery according to a test by measuring chronometer
  • Patient who signed informed consent
  • Subject affiliated to the social security system

Exclusion criteria

  • history of epilepsy or seizure
  • MEP Lack of ECR
  • Presence of a cons-indication for use of magnetic stimulation or MRI:
  • Surgical Clips, metal sutures, staples, stent
  • Osteosynthesis devices on the head or neck
  • Pacemaker
  • Implanted hearing aid
  • Ocular foreign body, shrapnel, bullets
  • Metal Worker
  • Heart Valve, endovascular equipment
  • Ventricular bypass valve
  • Pace-maker or neurostimulator
  • Claustrophobia
  • incapable adult Patient, safeguard justice, guardianship or trusteeship
  • Pregnant women and / or breastfeeding (because lack of data in the literature regarding the absence of foetotoxic effect)

Treatment and study plan

Paired Associative Stimulation

Procedure

Patient with Paired Associative Stimulation only

Paired Associative Stimulation + Motor Imagery exercises

Procedure

Patient with Paired Associative Stimulation + Motor Imagery exercises

Placebo Paired Associative Stimulation + Motor Imagery exercises

Procedure

Patient with placebo Paired Associative Stimulation + Motor Imagery exercises

Primary outcomes

  1. Effect of a reeducation session as assessed by amplitude of motor evoked potential

    Time frame: Day 1

    At the inclusion visit 25 minutes after stimulation

  2. Effect of a reeducation session as assessed by amplitude of motor evoked potential

    Time frame: Week 1

    25 minutes after stimulation

  3. Effect of a reeducation session as assessed by amplitude of motor evoked potential

    Time frame: Week 2

    25 minutes after stimulation

  4. Effect of a reeducation session as assessed by amplitude of motor evoked potential

    Time frame: Week 3

    25 minutes after stimulation

Secondary outcomes

  1. Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential

    Time frame: Week 1

    After the first stimulation

  2. Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential

    Time frame: Week 2

    After the second stimulation

  3. Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential

    Time frame: Week 3

    After the third stimulation

  4. Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential

    Time frame: Week 1

    After the first stimulation

  5. Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential

    Time frame: Week 2

    After the second stimulation

  6. Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential

    Time frame: Week 3

    After the third stimulation

  7. Intensity curve as assessed by variation of intensity of motor evoked potential

    Time frame: Week 1

    After the first stimulation

  8. Intensity curve as assessed by variation of intensity of motor evoked potential

    Time frame: Week 2

    After the second stimulation

  9. Intensity curve as assessed by variation of intensity of motor evoked potential

    Time frame: Week 3

    After the third stimulation

  10. Motricity of upper limb recovering as assessed by Fugl Meyer Score

    Time frame: Day 1

    After inclusion visit

  11. Motricity of upper limb recovering as assessed by Fugl Meyer Score

    Time frame: Week 3

    After the third stimulation

  12. Asymmetry index as assessed by resonance magnetic imaging

    Time frame: Day 1

    At the inclusion visit

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Study of the Effects of the Combination of Motor Imagery Exercises and Transcranial Magnetic Stimulation (TMS) Type PAS in Patients After Hemiplegic Stroke

Acronym: MIPAS

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
May 20, 2016
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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